Counterfeit Cancer Medicines Warning Issued by Cofepris

The Federal Commission for Protection from Health Risks (Cofepris) has issued a warning regarding the counterfeiting of several batches of medicines intended for cancer treatment corresponding to the companies Roche, Sanofi Pasteur, and Merck Sharp and Dohme.

Roche Medicines Affected by Counterfeiting

For Roche, Lots of H1079B02 and H7893B06 from the drug Mabthera (rituximab) in 500 mg/50 ml solution have been identified. Batch H1079B02, with an expiry date of March 16, 2024, has discrepancies in the secondary packaging. Batch H7893B06, for its part, is not recognized as a product manufactured by Roche or its subsidiaries, and does not contain the active ingredient.

Sanofi Pasteur Medicines Affected by Counterfeiting

Sanofi Pasteur reported the counterfeiting of the drug Beneflur (fludarabine) 10 mg, which comes in a box with 15 tablets and a bubble-like container inside a bottle. This product shows a best before April 2023 date and a lot number on the box of 960558, while the blister pack shows a different lot number: 00431D.

Merck Sharp and Dohme Medicines Affected by Counterfeiting

Merck Sharp and Dohme Comercializadora found counterfeit Keytruda (pembrolizumab) 100 mg/4 mL, solution for injection. The fake lot numbers include W038345 with an expiry date of 21MAY2024, X015587 with an expiry date of 10DEC2024, and In addition, batch DB50571 with an expiry date of FEB 2026 is not registered in the global batching system manufacturer’s wide.

Recommendations from Cofepris

Cofepris has recommended not to buy these products, because, due to their irregularity, the origin of the raw materials, as well as the conditions of manufacture, storage, transport, and handling, are unknown. Therefore, its safety, effectiveness, or quality cannot be guaranteed.

With information from SUN.